FDA.reportPublic FDA data

Sodium Diuril

Product NDC
76478-711
11-digit product format
764780711
Labeler code
76478
Product ID
76478-711_a069524a-f689-430f-8e0f-fe62240bcd5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorothiazide sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Akorn
Application
NDA011145
Marketing category
NDA
Marketing start
1958-10-03
Marketing end
0000-00-00
Substance
CHLOROTHIAZIDE SODIUM
Active strength
1 mg/18mL
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d305018-7d41-42ea-a6eb-85f5b05f9a63Product name320250429
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6823a9b2-3fe6-2173-aeb8-21d965ee1e1eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76478-711-402024-01-30C16284748780-11030e365-51c5-111a-e063-dadaa90a10e2Intravenous Sodium Diuril ® (chlorothiazide sodium)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76478-711-40Sodium Diuril18 mL in 1 VIALINJECTION1811
76478-711-40Sodium Diuril1 in 1 CARTONINJECTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76478-711-40EA - Each76478-711d21043d6-3a39-4ed7-9199-19f3496a4f6712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
chlorothiazide sodiumACTIVE INGREDIENTSN86FG7N2KSODIUM DIURIL (CHLOROTHIAZIDE SODIUM) INJECTION [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.)]4
chlorothiazideACTIVE MOIETY77W477J15HSODIUM DIURIL (CHLOROTHIAZIDE SODIUM) INJECTION [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.)]4
mannitolINACTIVE INGREDIENT3OWL53L36ASODIUM DIURIL (CHLOROTHIAZIDE SODIUM) INJECTION [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.)]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32ISODIUM DIURIL (CHLOROTHIAZIDE SODIUM) INJECTION [OAK PHARMACEUTICALS, INC. (SUBSIDIARY OF AKORN, INC.)]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76478-711SODIUM DIURIL (CHLOROTHIAZIDE SODIUM) INJECTION [AKORN]11Legacy NDC, 2 package rows20220706_1d9fa4e6-6516-45cd-a316-292c6a529ecc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484152chlorothiazide 500 MG InjectionPSN1d9fa4e6-6516-45cd-a316-292c6a529ecc11
996476Diuril Sodium 500 MG InjectionPSN1d9fa4e6-6516-45cd-a316-292c6a529ecc11
996476chlorothiazide 500 MG Injection [Diuril]SBD1d9fa4e6-6516-45cd-a316-292c6a529ecc11
484152chlorothiazide 500 MG InjectionSCD1d9fa4e6-6516-45cd-a316-292c6a529ecc11
484152chlorothiazide (as chlorothiazide sodium) 0.5 GM InjectionSY1d9fa4e6-6516-45cd-a316-292c6a529ecc11
996476Diuril 500 MG InjectionSY1d9fa4e6-6516-45cd-a316-292c6a529ecc11
996476Sodium Diuril 0.5 GM InjectionSY1d9fa4e6-6516-45cd-a316-292c6a529ecc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76478-711-40764780711401 VIAL in 1 CARTON (76478-711-40) > 18 mL in 1 VIAL1 vial1958-10-030000-00-00NoNoCurrent